January 2017 decisions news release

Four new medicines accepted for routine use in Scotland

The Scottish Medicines Consortium (SMC) has today (Monday 16 January) published advice accepting four new medicines for routine use in NHS Scotland.

Pembrolizumab (Keytruda) was accepted for the treatment of late-stage non-small cell lung cancer (NSCLC). It was considered through SMC’s Patient and Clinician Engagement (PACE) process, for medicines used at the end of life and for very rare conditions. In the PACE meeting, patient groups and clinicians highlighted the severe symptoms associated with late-stage NSCLC and the need for treatments that are better tolerated than those currently available. Pembrolizumab can offer patients around two months additional survival time which is valuable in the context of limited life expectancy.

Deferasirox (Exjade) was accepted for treatment of an excess of iron in the body resulting from frequent blood transfusions in some patients with a rare blood disorder known as Myelodysplastic Syndrome (MDS). This excess of iron can lead to heart, liver and kidney problems. Through PACE, patient groups and clinicians described the only other available treatment, which is given via an infusion pump worn overnight or under clothes for eight hours at a time on 5-7 days every week. Deferasirox offers an oral treatment for those patients for who use of the infusion pump is not an option.

Elbasvir-grazoprevir (Zepatier) was accepted for the treatment of chronic Hepatitis C. Elbasvir – grazoprevir is a combination of two medicines that inhibit the replication of the Hepatitis C virus and offers the prospect of a cure for Hepatitis C infection.

The Committee also accepted a buprenorphine skin patch (Butec) for use in people over 65 years old with chronic pain that is not associated with cancer. Buprenorphine is a painkiller which can be used to treat moderate chronic pain. Chronic pain is difficult to manage effectively and this buprenorphine patch, which is applied to the skin once a week, offers an alternative to oral treatment options.

Also accepted was dalbavancin (Xydalba) for the treatment of acute bacterial skin and skin structure (tissue below the skin) infections in adults. Dalbavancin is an antibiotic and can be used to treat infections such as cellulitis (inflammation of deep skin tissue), skin abscesses and wound infections. While this medicine was accepted by the Committee in October 2015, the decision could not be published until the medicine was made available for use in NHS Scotland.

Following consideration through the PACE process, the Committee was unable to accept daratumumab (Darzalex) for the treatment of patients at an advanced stage of multiple myeloma (a rare cancer of the white blood cells). The Committee was concerned that uncertainties in the company’s evidence on its benefits meant it would not be a good use of NHS resources.

The Committee was also unable to accept carfilzomib (Kyprolis) for the treatment of multiple myeloma. Carfilzomib was considered through PACE, which allows the Committee additional flexibility in its decision making. However, the Committee was not satisfied that the company’s evidence about the overall survival benefits offered by carfilzomib was strong enough to justify its cost to the NHS.
Professor Jonathan Fox, chairman of the SMC, said:

“I am pleased that we were able to accept four new medicines for routine use in NHS Scotland. Through our PACE meeting, we know that pembrolizumab for NSCLC will be welcomed by patients and their families.

“For patients suffering from iron excess as a result of blood transfusions for MDS, deferasirox will offer a welcome alternative treatment for those for whom an infusion pump is not an option.

“Eradicating hepatitis C is a key commitment for Scottish Government and new medicines for this condition will help achieve this aim. Buprenorphine skin patches will provide a further treatment option for moderate chronic pain in some patients.”

He added:

“Unfortunately the Committee was unable to accept two medicines for the treatment of multiple myeloma. With daratumumab, the Committee had concerns about uncertainty in the evidence the company presented about the medicine’s benefits, such that the Committee felt it would not be a good use of NHS resources.

“With carfilzomib, the Committee felt that the company’s evidence about the overall survival benefits of the medicine was not strong enough to justify its cost to the NHS.”